Sinus balloon dilation catheters and sinus surgery tools

This Application is a continuation of U.S. application Ser. No. 17/534,950 filed on Nov. 24, 2021, which is a continuation of U.S. application Ser. No. 16/275,229 filed on Feb. 13, 2019, now issued as U.S. Pat. No. 11,207,508, which is a continuation of U.S. application Ser. No. 14/927,904 filed Oct. 30, 2015, now issued as U.S. Pat. No. 10,238,846, which is a continuation of U.S. application Ser. No. 13/671,316 filed on Nov. 7, 2012, now issued as U.S. Pat. No. 9,192,748, which claims priority to PCT Patent Application No. PCT/US2011/035662 filed on May 7, 2011, which claims priority to U.S. Provisional Patent Application No. 61/332,575, filed May 7, 2010. The above-noted Applications are incorporated by reference as if set forth fully herein. Priority is claimed pursuant to 35 U.S.C. §§ 119, 120 and any other applicable statute.

Inventive subject matter disclosed herein generally relates to balloon inflation devices and methods. More particularly, the field of the invention relates to balloon dilation devices and methods for the treatment of sinusitis.

Sinusitis is a condition affecting over 35 million Americans, and similarly large populations in the rest of the developed world. Sinusitis occurs when one or more of the four paired sinus cavities (i.e., maxillary, ethmoid, frontal, sphenoid) becomes obstructed, or otherwise has compromised drainage. Normally the sinus cavities, each of which are lined by mucosa, produce mucous which is then moved by beating cilia from the sinus cavity out to the nasal cavity and down the throat. The combined sinuses produce approximately one liter of mucous daily, so the effective transport of this mucous is important to sinus health.

Each sinus cavity has a drainage pathway or outflow tract opening into the nasal passage. This drainage passageway can include an ostium, as well as a “transition space” in the region of the ostia, such as the “frontal recess,” in the case of the frontal sinus, or an “ethmoidal infundibulum,” in the case of the maxillary sinus. When the mucosa of one or more of the ostia or regions near the ostia become inflamed, the egress of mucous is interrupted, setting the stage for an infection and/or inflammation of the sinus cavity, i.e., sinusitis. Though many instances of sinusitis may be treatable with appropriate medicates, in some cases sinusitis persists for months or more, a condition called chronic sinusitis, and may not respond to medical therapy. Some patients are also prone to multiple episodes of sinusitis in a given period of time, a condition called recurrent sinusitis.

Balloon dilation has been applied to treat constricted sinus passageways for the treatment of sinusitis. These balloon dilation devices typically involve the use of an inflatable balloon located at the distal end of a catheter such as a balloon catheter. Generally, the inflatable balloon is inserted into the constricted sinus passageway in a deflated state. The balloon is then expanded to open or reduce the degree of constriction in the sinus passageway being treated to facilitate better sinus drainage and ventilation. At the same time most, if not all, of the functional mucosal tissue lining of the sinuses and their drainage passageways are preserved.

Exemplary devices and methods particularly suited for the dilation of anatomic structures associated with the maxillary and anterior ethmoid sinuses are disclosed, for example, in U.S. Pat. No. 7,520,876 and U.S. Patent Application Publication No. 2008-0172033. Other systems have been described for the treatment of various other sinuses including the frontal sinus. For example, U.S. Patent Application Publication No. 2008-0097295 discloses a frontal sinus guide catheter (FIG. 6B) and method of treating the frontal sinuses (e.g., FIGS. 8B-8C). U.S. Patent Application Publication No. 2008-0125626 discloses another guide device (e.g., FIGS. 10C and 10C′) for transnasal access to the frontal sinuses for treatment.

Some of the embodiments of the invention disclosed herein include a device for dilating a sinus cavity lumen. The device includes a guide tube, having a proximal end and a distal end that terminates in a malleable distal tip. The device also includes a sleeve member, annularly positioned over the guide tube. The sleeve is movable relative to the guide tube and is capable of being advanced over the guide tube. The device also includes a balloon that is coupled to the sleeve. The balloon is extendable and inflatable at or beyond the end of the guide tube.

The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments, which are also referred to herein as “examples,” are described in enough detail to enable those skilled in the art to practice the invention. The embodiments may be combined, other embodiments may be utilized, or structural, and logical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.

In this document, the terms “a” or “an” are used to include one or more than one and the term “or” is used to refer to a nonexclusive “or” unless otherwise indicated. In addition, it is to be understood that the phraseology or terminology employed herein, and not otherwise defined, is for the purpose of description only and not of limitation. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

1 1 FIGS.A andB 10 10 illustrate two views of one embodiment of balloon dilation catheterof the invention. Catheteris useful for treating sinusitis by dilating the sinus ostia or other portions of sinus cavity drainage pathways.

10 14 20 21 14 18 14 19 14 19 14 14 Balloon dilation catheterincludes tubular guidehaving distal endthat terminates in malleable distal tip. Tubular guideencloses lumenthat extends the length of tubular guide. Sleeve memberalso defines a lumen in which is annularly positioned tubular guide. Sleeve memberis capable of being advanced over tubular guidein a direction parallel with the major axis of tubular guide.

10 12 14 12 19 14 12 19 12 19 2 12 47 47 21 14 19 47 21 14 1 1 FIGS.A andB Catheteralso includes handle. Tubular guideis longitudinally static relative to handle. Sleeve memberis movable longitudinally along tubular guiderelative to handle. Sleeve memberis then not longitudinally static relative to handle. Sleeve memberincludes chamfered distal endwhich has a enlarged diameter near its proximal end and handleand terminates distally at ball tip. Ball tipis positioned at or beyond malleable tipof tubular guide. Whileillustrate an embodiment where sleeve memberterminates in ball tipthat is positioned at or beyond malleable tipof tubular guide, in some embodiments, the sleeve member does not include a ball tip and the sleeve member may terminate at a position that is proximal to the malleable tip of the tubular guide when in a fully retracted state and terminate at a position that is distal to the malleable tip of the tubular guide when in a fully extended state. In further embodiments, the sleeve member does not include a ball tip and the sleeve member terminates at a position that is just distal to, but abuts, the malleable tip of the tubular guide when in a fully retracted state and terminates at a position that is distal to, and does not abut, the malleable tip of the tubular guide when in a fully extended state.

14 20 14 Tubular guideis a malleable stainless steel hypotube and its distal endhas a degree of malleability wherein a user may bend or impart a desired shape or configuration to distal end of guide tube. As used herein, the term, “malleable” refers to a tip, material, or element of the invention that is capable of being permanently shaped, bent, or otherwise deformed by forces typically produced by manual manipulation of a human user so that the tip, material, or element retains the deformation.

For some embodiments, the proximal end of the tubular guide of any of the catheters described herein is constructed using a material having greater rigidity than the distal end or the malleable tip of the tubular guide. In some embodiments, the tubular guide of any of the catheters described herein is not malleable, but is pre-formed into a particular shape and not intended to be reshaped by the user. In some embodiments, the tubular guide of any of the catheters described herein does not have an internal lumen and is a solid rod.

14 24 10 23 24 23 14 Tubular guideextends to proximal endof catheterand interfaces in a sealed arrangement with portdisposed at proximal end. Portprovides access to the lumen of tubular guidefor the purposes such as irrigation, aspiration, placement of guidewires, illuminated guidewires or devices, or the like.

13 19 14 Distal sleeve portionis constructed from a material that is suitably soft or compliant so it can contact tissue of a sinus ostium or sinus drainage pathway without causing substantial trauma. As used herein, “soft” and “compliant” refers materials or elements of the invention that are capable of being shaped, bent, or otherwise deformed by relatively small forces (e.g., those typically produced by manual manipulation of a human user or from slight pressure by being pressed against tissue) but do not retain the deformation once the force is removed. “Soft” and “complaint” materials are not malleable. Suitable soft or compliant materials can include silicone and thermoplastic materials (e.g., polyethylene or PEBAX). In other embodiments, at least the distal sleeve portion of a sleeve member is formed from a material that is malleable so that the distal sleeve portion can be shaped and the distal sleeve portion can maintain its shape. In some embodiments, the distal sleeve portion of a sleeve memberis constructed of a soft and deflectable material while the tubular guideis constructed of a more rigid, though malleable, stainless steel hypotube.

14 20 1 1 FIGS.A andB 1 1 FIGS.A andB Tubular guidemay be pre-shaped to have a bend as is illustrated in distal endin. The nature and degree of the bend may be configured to match with the frontal sinus tract or frontal recess. For other embodiments, the distal end of the tubular guide is malleable and is not pre-shaped in the form of the bend illustrated in.

17 19 19 14 17 19 17 30 17 19 17 19 14 Balloonis positioned on or incorporated into sleeve memberand travels with sleeve memberlongitudinally over the length of tubular guide. Balloonis mounted on sleeve memberso as to form a fluidic seal between balloonand inflation lumen. Balloonis bonded to sleeve memberusing a weld, adhesive, or the like. In another embodiment, the balloon is secured to the sleeve member using a mechanical connection. Generally, any technique known to those skilled in the art may be used to secure to the balloon to the sleeve member. Given that balloonis secured directly to sleeve member, both structures are slidably mounted over tubular member.

19 32 12 210 10 12 32 12 32 12 19 14 47 13 20 14 32 13 21 13 32 13 17 21 13 17 14 12 2 FIG.E Sleeve memberis mechanically linked to pushing memberand the other components of handlein a manner similar to that illustrated inand described with reference to balloon dilation catheter(described below). In use, a practitioner of catheterholds handleand, using one of his/her fingers, slides pushing membertowards the distal end of handle. As pushing memberis translated towards distal end of handle, sleeve membertranslates along the length of tubular guide. Ball tipand distal sleeve portionmove distally along the longitudinal length distal endof tubular guide. With increased translation of pushing member, an increasing length of distal sleeve portiontranslates off distal tipof distal sleeve portion. With sufficient translation of pushing member, all or some portion of the length of distal sleeve portionand all or some portion of ballooncan be directed longitudinally off of distal tip. In this manner, some or all of distal sleeve portionor ballooncan be extended distally off of tubular guideand relative to handle.

17 30 19 30 10 1 1 FIG.A orB The interior portion of balloonis in fluid communication with inflation portvia an inflation lumen (not illustrated in) defined by the distal portion of sleeve member. An inflation device (not illustrated) may be connected to inflation portand a fluid (e.g., liquid water). One exemplary inflation device that may be used in connection with balloon dilation catheteris described in U.S. patent application Ser. No. 12/372,691, which was filed on 17 Feb. 2009, published as U.S. Pat. Pub. 2010/0211007 and is incorporated by reference as if set forth fully herein. Other inflation devices may also be used.

10 19 17 14 47 19 20 14 13 21 20 18 17 20 21 19 14 10 13 14 10 1 FIG.A 1 FIG.B 1 FIG.B 1 FIG.B Balloon dilation catheteris shown in a retracted position inand in an extended position in. In the retracted position, sleeve memberand balloonare positioned over tubular guideand ball tipof sleeve memberabuts distal endof tubular guide. In the extended position illustrated in, most of distal sleeve portionhas translated distally off of distal tipof malleable distal endof tubular guideand balloonis now positioned on distal endand more proximal to distal tip. In the retracted position, the entire length of sleeve memberis directly supported by the more rigid tubular guideand cathetercan be used as a probing instrument that will provide relatively good tactile feedback. In the extended position shown in, distal sleeve portionis no longer directly supported by the more rigid tubular guideis more deflectable than compared to when it is in the retracted position and cathetercan be used as a probing instrument with distal portion that is less likely to traumatize tissue.

In some embodiments (e.g., embodiments where the distal sleeve portion does not include a ball tip), when the balloon dilation catheter is in a fully retracted position, some portion or all of a distal end of a tubular guide extends out from the distal end of sleeve member and is exposed. In such embodiments, when the balloon dilation catheter is placed in an extended position, the distal sleeve portion and possibly some portion or all of the balloon is translated past the malleable distal end of the tubular guide such that the entire length of the tubular guide becomes enveloped by the sleeve member and no portion of the tubular guide is exposed.

10 10 10 13 20 10 17 10 17 14 17 30 In operation, catheteris directed into a patient's nasal cavity and the distal portions of cathetercan be used to probe sinus passageways in order to find a desired dilation treatment site. In a fully retracted position, catheteris a tool that provides the user relatively good tactile feedback during his/her probing. If desired, a user may extend distal sleeve portionoff of distal end, thereby providing cathetera less rigid and more deflectable distal portion, relative to the retracted position, with which he/she can probe the sinus anatomy in a manner that is less likely to cause trauma to contacted tissue. Once the physician identifies the treatment site, the physician positions balloonin the desired location, either by manipulating the entire catheter, translating balloonalong tubular guide, or both. The physician can then inflate balloonusing an inflation device that is in fluid communication with inflation lumen.

23 18 47 23 18 47 10 Portmay be configured with a conventional interface (e.g., a Luer connector) and may be used as an aspiration port or a port for directing fluids and/or medicaments through lumenand out ball tip. Alternatively, or in addition, a guidewire can be directed through portand lumenand out of ball tipin order to assist a user in positioning catheterin a desired portion of a patient's anatomy.

2 2 FIGS.A-G 2 2 FIGS.A-C 2 FIG.D 2 FIG.E 2 2 FIGS.F andG 210 210 217 210 210 210 illustrate another embodiment of the invention represented as balloon dilation catheter.shows partial cut-away views of a distal end portion of catheterillustrating a sequential extension and dilation of balloon,illustrates a perspective view of catheter,illustrate a cut-away view of catheter, andillustrate a cross-sectional profile of two different positions along the length of catheter.

210 212 214 218 220 221 219 230 223 10 210 239 223 218 221 213 Balloon dilation catheterincludes handle, tubular guidedefining lumenand including distal endand distal tip, sleeve member, inflation port, and suction portand these portions operate and have functions similar to those described in relation to dilation catheter. Catheteralso includes guidewire, which is directed and situated through port, along the length of lumen, and out distal tipand distal sleeve portion.

8 FIG. 2 FIG.A 910 910 912 914 916 918 922 920 914 914 916 922 In some embodiments, a guidewire is not directed through the suction port but instead, an elongate member that is flexible, soft, compliant, deflectable, or malleable is an attached permanent portion of the balloon dilation catheter by, for example, being attached to the sleeve portion (e.g., attached to the distal end of the sleeve portion), secured to the tubular guide, or secured to a lever on the handle which can be advanced in order to advance the guidewire distally relative to the tubular guide or sleeve member.illustrates a distal portion of balloon dilation catheterwhich is just one embodiment of a balloon dilation catheter of the invention. Balloon dilation catheterincludes balloonsituated on the distal end of sleeve memberand arranged over distal endof tubular guide, similar to the embodiments of the invention illustrated in. In this embodiment, however, elongate memberis attached to distal endof sleeve member. When sleeve memberis advanced or extended off of distal end, elongate membercan be used to probe sinus passageways. In some embodiments, the elongate member is pre-shaped or is slightly malleable so that it can hold a shape imparted to it by a user of the catheter. In further embodiments, the elongate member is additionally or alternatively flexible, compliant, soft, and deflectable so that it can be used to gently probe sinus passageways.

210 217 210 219 213 213 219 239 219 239 213 239 219 1 1 FIGS.A andB 1 1 FIGS.A andB Turning back to catheter, balloonof catheteris situated closer to the distal end of sleeve membercompared to the embodiment illustrated in. Hence, distal sleeve portionis shorter than the distal sleeve portion illustrated in. Distal sleeve portionhas a smaller inner diameter than the more proximal portions of sleeve memberand only slightly larger than the outer diameter of guidewire. Hence, the distal end of sleeve member“necks down” around guidewireso that distal sleeve portiontracks over guidewirewhen sleeve memberis extended from a more retracted position.

220 213 239 220 214 Distal endis malleable yet relatively more rigid than distal sleeve portionor guidewire. Distal endmay be manually formed into a variety of configurations so that tubular guidecan be adapted for a given application (e.g., shapes that accommodate a patient's anatomy).

214 221 Examples of suitable shapes into which tubular guidecan be formed include “U” shapes where distal tipbent back in a retrograde fashion. Such a shape may be useful in accessing hard-to-reach ostia or other structures (e.g., the maxillary ostium or the infundibulum via a transnasal route).

213 247 217 239 213 217 239 239 Distal sleeve portionand the inner surfaceof balloonis made of a material that is more complaint and deflectable than guidewireso that distal sleeve portionand ballooncan track over guidewireduring extension without pulling on guidewire with an undesirable amount of force that could dislodge guidewirefrom a desired position. In some embodiments, the distal sleeve portion and inflatable balloon portion is more rigid than the guidewire. In some embodiments, the outer surface of the balloon is made of a material that is less compliant than the inner surface so that the balloon behaves as a non-compliant balloon during inflation.

213 245 245 213 245 213 213 Sleeve memberincludes or is attached to proximal sleeve portion. Proximal sleeve portionis made of a material more rigid (e.g., stainless steel) than the other portions of sleeve member. Proximal sleeve portionreinforces the proximal portions of sleeve memberand provides sleeve memberwith increased column strength.

2 FIG.A 210 210 217 220 221 214 213 221 illustrates a distal portion of catheterwhen catheteris in a fully retracted position. In this retracted position, balloonoverlies distal endand distal tipof tubular guideand distal sleeve portionabuts distal tip.

2 FIG.B 2 FIG.D 219 241 242 213 217 220 214 239 213 217 232 232 212 213 217 illustrates the extension of sleeve memberlongitudinally along directionsand. During extension, distal sleeve portionand balloonare advanced off of distal endof tubular guideand track along the exposed distal portions of guidewire. Distal sleeve portionand balloonare mechanically linked to pushing member(illustrated in). Advancing pushing memberdistally relative to handlecauses distal sleeve portionand balloonto advance.

2 FIG.C 2 2 FIGS.A andB 210 217 248 217 illustrates catheterin an extended state. Balloonhas been inflated such that non-complaint outer surfaceof balloonhas increased in diameter compared to the illustrations of.

2 FIG.E 210 219 232 illustrates a cross-section view of catheter. Sleeve memberis mechanically linked to pushing memberin a manner similar to that described in relation to FIGS. 3B and 4 of US Pat. Pub. 2010/0312101 (the entire teachings of which are incorporated herein by reference).

2 FIG.F 2 FIG.E 210 2 245 219 219 218 214 249 249 217 230 249 230 245 274 275 212 274 219 214 230 274 214 232 274 245 illustrates a cross-section view of catheterat the point indicated as “F” in. Proximal sleeve portiondefines a lumen in which resides sleeve member. Sleeve member, in turn, defines lumen, in which resides tubular guide, and inflation lumen. Inflation lumenis in fluid communication with balloonand inflation port. Inflation lumenis placed in fluid communication with inflation portin a manner similar to that illustrated in FIG. 4 of US Pat. Pub. 2010/0312101. Specifically, proximal sleeve portionincludes helical portionin recessed regionof handle. Helical portionfacilitates the distal advancement or extension and proximal retraction of sleeve memberalong tubular guide, yet still maintains fluid communication with port. Helical portionis in the shape of a helix that wraps around tubular guideand is configured to elongate and contract upon movement of pushing member. Helical portionmay be formed by “skiving” away a portion of proximal sleeve portion.

2 FIG.G 2 FIG.E 2 FIG.G 210 2 212 214 218 219 249 illustrates a cross-sectional view of catheterat the point indicated as “G” in. For clarity, portions of handlehave been omitted from. In this view, tubular guidedefines lumenand is situated next to a portion of sleeve memberthat defines inflation lumen.

2 2 FIGS.H-K 2 2 FIGS.H-K 210 210 200 201 203 illustrate various cross-sectional views (sagittal plane) of a frontal sinus of a subject undergoing treatment with balloon dilation catheter. While positions for catheterare described herein, it is understood that substantially the same positions are employed for deployment of other catheter embodiments of the invention. The cross-sectional views illustrate a nasal passageway, a frontal recess, and a frontal sinus cavity. Whileillustrate the treatment of a drainage pathway for a frontal sinus cavity, it will be understood that similar methods can be used to treat the drainage pathways of the other sinus cavities (e.g., maxillary and sphenoid sinus cavities).

2 FIG.H 210 200 210 217 220 214 201 239 210 203 220 239 210 220 239 As shown in, balloon dilation catheteris inserted into the nasal passagewaywhile catheteris in a retracted position with balloonin a deflated state. Distal endof tubular guideis then positioned within or near the entrance to frontal recessand a distal end portion of guidewireis directed through catheterand positioned in frontal sinus cavity. This positioning of tubular guide distal endand guidewiremay be accomplished under endoscopic visualization using a conventional endoscope such as a Hopkins rod-type endoscope that is positioned alongside balloon dilation catheter. Alternatively, or in addition, imaging guidance or CT imaging systems may be use to position endor guidewire.

239 203 239 239 203 239 210 203 Confirmation of accurate positioning of guidewirewithin frontal sinus cavitycan be accomplished by fluoroscopically viewing guidewire. If correctly positioned, the distal end portion of guidewirewill be seen to loop within the frontal sinus cavity. If fluoroscopy does not confirm the correct position, the guidewireis retracted back into catheter(optionally, catheter may also be repositioned) and then passed into another passage suspected of being the entrance to frontal sinus cavityand confirmation is again checked via fluoroscopic images.

239 As an alternative or supplement to fluoroscopic confirmation, guidewiremay be a light-emitting guidewire such as that disclosed in U.S. Pat. Pub. 2007/0249896, which is incorporated by reference herein.

239 203 232 213 239 217 213 239 213 239 2 FIG.I Once guidewireis placed within frontal sinus cavity, pushing memberis advanced in the distal direction thereby advancing distal sleeve portionalong guidewireuntil balloonis located at the desired dilation site (as shown in). Because distal sleeve portionhas been “necked down” to closely track guidewire, distal sleeve portionwill be less likely to scrape or otherwise injure sinus tissue as it is advanced along guidewire.

217 201 217 230 249 217 217 201 201 217 217 201 2 FIG.I 2 FIG.J After balloonis positioned in the desired location (e.g. in frontal recess, as shown in), balloonis inflated. Inflation is accomplished by coupling an inflation device (not shown) to inflation port. The inflation device may include a syringe or the like that is depressed to direct a fluid into inflation lumenand into the interior of balloon, thereby causing inflation of balloonto the state illustrated inand widening or remodeling of the bone and other tissue defining frontal recess. Pressures typically used to accomplish widening or remodeling of frontal recessare within the range of about 3 atmospheres to about 18 atmospheres, about 8 to about 14 atmospheres, or about 12 atmospheres. Balloonmay be inflated only a single time or, alternatively, may be inflated, deflated, and inflated again a plurality of times in order to achieve the desired degree of widening. Each inflation step may be performed after positioning balloonin a different position within frontal recess.

201 217 201 203 2 FIG.K 2 FIG.K After frontal recesshas been widened or otherwise remodeled, balloonis deflated and removed as illustrated in. The now widened frontal recessillustrated inis believed to restore the drainage and aeration function and health of frontal sinus cavity.

104 220 214 In certain patients, treatment of one or both frontal sinusesas described above may be adequate. In other patients, additional or alternative sinuses may need to be treated, particularly the maxillary and/or anterior ethmoid sinuses by dilation of the maxillary ostium or the ethmoid infundibulum. In such patients, a combination procedure may be well suited. Distal endof tubular guidecan be shaped to accommodate treatment of the drainage pathways of those other sinus cavities. Alternatively, or in addition to, the catheters described herein can be used in combination with one of the devices or systems described in U.S. Pat. No. 7,520,876 or U.S. Pat. Pub. 2008/0172033, the entire teachings of which are incorporated herein by reference. Alternatively, or in addition to, the frontal or other sinuses could be treated more conventionally using surgical techniques such as, for instance, functional endoscopic sinus surgery (FESS) or via pharmaceutical substances.

Also, the sphenoid sinus outflow tracts could be dilated with one or more of the catheters described herein. It is also contemplated that the catheters described herein could be used to dilate the maxillary sinus outflow tract via a trans-canine fossa route. Suitable access tools are described in co-pending U.S. patent application Ser. No. 12/038,719, filed on 27 Feb. 2008, published as U.S. Pat. Pub. 2009/0216196, and which is incorporated in its entirety by reference herein.

6 6 FIGS.A-D 610 610 612 632 619 617 645 614 630 623 632 Another embodiment of the invention is illustrated inas balloon dilation catheter. As with the previously described embodiments, catheterincludes handleon which is mounted sleeve pushing member, sleeve memberthat includes balloonand proximal sleeve portion, malleable tubular guide, inflation port, access port, and sleeve pushing member.

610 647 648 647 648 648 650 650 651 651 634 648 617 620 614 6 FIG.C Catheteralso includes a tubular guide extension in the form of advanceable ball tipand distal rod(illustrated in). Advanceable ball tipis positioned at the end of distal rod. Distal rodis mechanically linked to proximal rod. Proximal rodis mechanically linked to pushing rod. Pushing rodis mechanically linked to tip-advancement pushing member. Distal rodis made of a relatively rigid material (e.g., stainless steel) that provides balloonimproved column support when it is tracked off of distal endof tubular guide, compared to embodiments of the invention where a balloon is tracked off a tubular guide and onto a relatively flexible member (e.g., a guidewire). In some embodiments the distal rod is made of a rigid, yet malleable material. In some embodiments, rods and other components used to mechanically link the proximal rod to the tip-advancement pushing member are internal to the handle.

647 648 614 617 619 614 648 610 634 652 647 648 620 614 610 648 614 647 620 614 610 648 614 647 620 610 617 619 617 614 620 647 6 6 FIGS.B-D 6 FIG.A 6 FIG.B 6 FIG.C 6 FIG.D 6 FIG.D Advanceable ball tipand distal rodcan be extended and retracted from tubular guideand balloonand sleeve membercan be advanced off of tubular guideand over distal rod, as illustrated inwhich show a sequence of three profile views of catheter. When tip-advancement pushing memberis directed proximally and distally along direction(shown in), advanceable ball tipand distal rodare directed in and out of distal endof tubular guide.illustrate catheterwith the tubular guide extension in a fully retracted position, with distal rod(not shown) fully retracted into tubular guideand ball tipabutting distal endof tubular guide.illustrates catheterwith the tubular guide extension in an extended position, with distal rodextended out of tubular guideand ball tipno longer abutting distal end.illustrates catheterwith balloonand sleevein an extended position. Balloonhas been advanced over tubular guide(not shown in), off of its distal end, and now abuts ball tip.

648 647 610 617 614 610 648 614 610 617 614 648 The tubular guide extension, comprising distal rodand ball tip, of catheterenables a user to advance balloonoff of tubular guidein order to increase the effective “reach” of catheter. Because distal rodis made of a rigid material, even when extended from tubular guidethe tubular guide extension can provide improved tactile feedback to a user of catheterin order to assist in probing sinus anatomy. When a desired dilation position is identified, ballooncan be tracked to that site by advancement over and off of tubular guideand onto distal rod.

6 FIG.E 610 614 614 647 648 648 678 678 614 678 650 678 614 648 620 614 634 651 650 678 647 678 650 647 illustrates a cross-section view of the distal end of catheterin which the distal portion of tubular guidehas been positioned in a 90-degree bend relative to the proximal portion of tubular guide. Ball tipis attached to distal rod. Distal rodis in turn attached to pushing wire. Pushing wirelies within the lumen defined by tubular guideand the proximal portion of pushing wireis attached to a distal end of proximal rod. Pushing wireis flexible so that it can negotiate bends or other deformation placed in the distal end of tubular guide, yet has enough column strength so that it can force distal rodin and out of distal endof tubular guide. When pushing memberis directed proximally and distally, that motion in turn moves rodsandas well as wireand tipsince wireis attached to the distal end of rodand tip.

7 FIG. While the above embodiments of the invention have been described as balloon dilation catheters having a sleeve member and balloon that are advanced longitudinally along a tubular guide, some embodiments of the present invention include balloon dilation catheters having a sleeve member and balloon that can be advanced both longitudinally and circumferentially about a tubular guide. Some of these circumferentially-positionable catheter embodiments include a handle having a pushing member that can be translated distally and proximally along the longitudinal axis of the handle as well as circumferentially around the longitudinal axis. In this way, a user of a circumferentially-positionable catheter embodiment of the invention can hold the catheter in one hand and use a single digit to both advance the balloon distally off of a tubular guide and then pivot the balloon about the axis of the tubular guide. Such an embodiment is illustrated in.

7 FIG. 1 FIG.A 710 710 10 747 illustrates balloon dilation catheter. Balloon dilation catheteris similar to balloon dilation catheterofin that it includes a sleeve member that, when in a fully retracted position, abuts the distal end of the tubular guide and, in an extended position, the distal sleeve portion and its ball tiptranslate off of the distal end of the tubular guide.

710 10 710 732 719 713 717 732 741 719 743 732 742 712 719 744 One difference between balloon dilation catheterand catheteris that catheterincludes pushing memberwhich can be translated in at least two different dimensions in order to move sleeve memberand its components (e.g., distal sleeve portionand balloon) in a similar manner. For example, moving pushing memberalong longitudinal directioncauses portions of sleeve memberto move along the longitudinal length of the tubular guide (not illustrated) parallel to direction. Similarly, moving pushing memberalong circumferential directionabout handlecauses portions of sleeve memberto move in circumferential directionabout the longitudinal axis of the tubular guide.

This ability to both translate a sleeve member off of a tubular guide and pivot it about the tubular guide can increase a balloon dilation catheter's probing ability, particularly if the sleeve member is attached to a soft, deflectable, or malleable tip portion (e.g., a soft or malleable guidewire). Any of the balloon dilation catheter embodiments described herein can include a sleeve member which can move both longitudinally along and circumferentially about a tubular member.

316 326 3 3 FIGS.B andC Inventive balloon embodiments disclosed herein include balloon embodimentsandshown in, respectively.

315 315 325 314 319 320 325 321 320 321 325 323 322 322 325 324 3 FIG.A One prior art balloon is shown atin. Prior art balloonhas a distal waistA that is bonded to sleeve memberA. As sleeve memberA is advanced over tubular guideA, distal waistA abuts ball tipA of tubular guide. When abutting ball tipA, waistA causes a set-back in balloon bodyA of about distanceA. DistanceA is equal to the length of waistA and the length of shoulderA.

322 It has been recognized that, for some purposes, having the full-dilation diameter of a balloon as close to the distal end of a tubular guide would be beneficial. In other words, it would be useful to keep distanceA as small as possible.

3 FIG.B 316 316 325 314 316 316 324 325 324 323 316 321 314 320 illustrates one embodiment of the invention that includes balloon. Balloonincludes distal waistB which is bonded to sleeve memberB. Balloonis shaped such that, when inflated, balloonhas wingsB that roll forward and over waistB. WingsB have an outer diameter that is approximately equal to that of balloon bodyB. In this manner, when inflated, the effective inflation diameter of ballooncan be brought as close to ball tipB when sleeve memberB is translated distally along tubular guideB.

3 FIG.C 3 FIG.A 326 326 325 314 325 324 325 322 323 321 illustrates another embodiment of the invention that includes balloon. Balloonincludes distal waistC which is bonded to sleeve memberC. Distal waistC is invaginated or folded under shoulderC. Invaginating distal waistC reduces distanceC between the balloon bodyC and ball tipC, relative to a similar balloon that does not include an invaginated distal waist (e.g., the embodiment illustrated in).

3 FIG.A 3 3 FIG.B orC 3 3 FIG.B orC Hence, some embodiments of the present invention include the balloon catheters described herein having a balloon bonded to a sleeve member as illustrated in. Alternatively, other embodiments of the present invention include the balloon catheters described herein having a balloon bonded to a sleeve member as illustrated in either of. Furthermore, other embodiments of the present invention include balloon dilation catheters substantially as described in US Pat. Pub. 2010/0312101, which was filed by John Drontle and Anthony Hanson on 5 Jun. 2009, assigned U.S. application Ser. No. 12/479,521, and is incorporated in its entirely herein by reference, but having a balloon portion attached to a sleeve member (or the “inner shaft” of the embodiments described by Drontle, et al. in US2010/0312101”) in the manner described with respect to.

4 FIG. 410 410 411 414 411 412 416 418 410 411 410 410 411 412 414 411 412 411 414 411 Another embodiment of the invention is illustrated inwhich illustrates balloon dilation catheterwhich is a balloon dilation catheter taught in US2010/0312101. Catheterincludes fiber-optic endoscope. Distal endof endoscopehas been inserted through suction port, along the inner lumen, and to the distal endof endoscope. Combining endoscopewith catheterin this way enables a user of catheterto view anatomy in front of endoscope. In some embodiments of the invention, a Tuohy-Borst adaptor is mounted to portwhich allows a user to lock the position of distal endof endoscope relative to endoscope. In further embodiments, a Y-adaptor is mounted to portso that endoscopecan be directed through one arm of the adaptor and a cleaning fluid (e.g., saline or water) can be directed through the other arm to clean distal endof endoscopeduring use.

5 FIG. 5 FIG. 510 510 512 516 514 510 518 516 520 516 510 530 Another embodiment of the invention is illustrated inas balloon dilation catheter. Catheterincludes balloonwhich can be advanced over tubular guideusing pusher memberin order to dilate tissue in much the same was as is described in the embodiments mentioned previously or as described in US2010/0312101. In addition, catheterincludes a debrider function that can macerate tissue and bone and carry the resulting debris out of the surgical field. This is accomplished at notchwhich provides a passageway between the exterior surface of tubular guideand inner lumendefined by tubular guide. As illustrated in, catheterincludes ball tipon its distal end. In some embodiments, the catheter includes a pointed tip that is useful for penetrating tissue or bone.

524 516 518 518 532 518 518 518 520 516 526 512 522 Water or saline is directed through fluid supply port, travels up a water supply lumen defined in tubular guide, and sprays out from the distal side of notch. The distal end of the water supply lumen is pointed back towards the proximal side of notch(i.e., in a retrograde fashion) so that the resulting water jetsfrom the distal side of notchto the proximal side of notch. Proximal side of notchis in fluid communication with suction lumendefined by tubular guideand with suction port. Balloonis inflated via inflation port.

524 526 518 520 526 518 518 520 518 518 518 518 518 During use, a practitioner of this embodiment of the invention attaches a water supply line to portand a suction source to port. Water travels up the water supply line and is directed backwards so that it travels from the distal to the proximal sides of notch. At the proximal side, the attached suction source draws the water back down lumenand out port. The water is directed with such force that any tissue or bone that enters notchis cut and macerated by the water. The pressure of the water jets in notch, combined with the suction forces at the distal end of lumen, result in a water vortex forming in notchwhich can produce a suction force near notchand assist in drawing loose tissue and bone pieces into the cutting streams of water so that the tissue can be macerated and carried away from the surgical site. The flow rates of the water supplied to notchand the suction force applied to notchare matched so that water and macerated tissues are carried away and do not accumulate in notch.

510 In this manner, catheterprovides both a tissue removal function similar to micro debriders commonly used in ENT procedures as well as a balloon-dilation function.

610 6 FIG.D While embodiments of the present invention have been shown and described, various modifications may be made without departing from the scope of the present invention. Relative sizes and dimensions shown in the various figures can be altered in order to suite a specific application. For example, the invention includes balloon dilation catheters that are similar to cathetershown inbut have a balloon that is shorter such that it can be extended completely past the bend in the malleable distal end of the tubular guide. The invention, therefore, should not be limited, except to the following claims, and their equivalents.